FINDINGS OF SCIENTIFIC MISCONDUCT
NIH GUIDE, Volume 25, Number 10, March 29, 1996
P.T. 34
Keywords:
Ethics/Values in Science & Technol
Grants Administration/Policy+
Department of Health and Human Services
Notice is hereby given that the Office of Research Integrity (ORI)
has made final findings of scientific misconduct in the following
cases:
Gail L. Daubert, R.N., Northwestern University: Based on an
investigation conducted by its Division of Research Investigations,
ORI found that Gail Daubert, R.N., while serving as clinic
coordinator for the Collaborative Ocular Melanoma Study (COMS) at
Northwestern University, committed scientific misconduct by
falsifying clinical trial data. The multicenter COMS involves
research on the treatment of choroidal melanoma, a rare form of eye
cancer. It is supported by the National Eye Institute. The study is
still ongoing, and no results have been published.
ORI found that Ms. Daubert falsified 211 data items, including
falsely stating that a radiation oncologist had evaluated patients
prior to randomization, falsely reporting laboratory blood test
results were normal when they were abnormal, falsely reporting that
dates for patient visits or procedures had been performed within the
specified protocol window when the actual date was outside the
protocol window, and falsely reporting that a COMS certified examiner
had performed an evaluation or procedure when a non-certified
examiner had performed the task.
Ms. Daubert has entered into a Voluntary Exclusion Agreement with ORI
in which she does not admit to any acts of scientific misconduct, but
she has agreed to exclude herself voluntarily, for the three year
period beginning March 4, 1996, from:
(1) contracting or subcontracting with any agency of the United
States Government and from eligibility for, or involvement in,
nonprocurement transactions (e.g., grants and cooperative agreements)
of the United States Government, as defined in 45 C.F.R. Part 76 and
48 C.F.R. Subparts 9.4 and 309.4 (Debarment Regulations); and
(2) serving in any advisory capacity to PHS, including but not
limited to service on any PHS advisory committee, board, and/or peer
review committee, or as a consultant.
The above voluntary exclusion, however, shall not apply to Ms.
Daubert's future training or practice of clinical medicine as a
nurse, unless that practice involves research or research training,
or to Ms. Daubert's participation in or eligibility for any Federal
program relating to student loans, education grants, or educational
assistance of any type or kind, for which she would otherwise be
qualified to receive or be considered to receive (educational
assistance), unless that educational assistance involves research or
research training.
Cathy Q. Lee, Massachusetts General Hospital: On February 28, 1996,
ORI found that Cathy Q. Lee, Ph.D., Postdoctoral Fellow, Molecular
Endocrinology Laboratory at the Massachusetts General Hospital,
committed scientific misconduct by engaging in falsification and
fabrication of research data incorporated in a manuscript prepared
for submission (but not submitted) to the EMBO Journal (Lee, C.Q.,
Yun, Y., and Habener, J.F. "Transactivation of functions of cAMP-
responsive transcription factor CREB-327 mediated by amphiphatic
helical domains flanking the requisite serine-119 phosphorylated by
protein kinase-A.") and by engaging in improper data selection and
falsification of data published in the EMBO Journal (Lee, C.Q., Yun,
Y., Hoeffler, J.P., and Habener, J.F. "Cyclic-AMP responsive
transcriptional activation of CREB-327 involves interdependent
phosphorylated subdomains." EMBO Journal 9:4455-4465, 1990.). This
research was supported by a Public Health Service grant.
Dr. Lee has entered into a Voluntary Exclusion Agreement with ORI in
settlement of ORI's finding of scientific misconduct and has agreed:
(1) to exclude herself voluntarily from any contracting or
subcontracting with any agency of the United States Government and
from eligibility for, or involvement in, Federal nonprocurement
transactions (e.g., grants and cooperative agreements) of the United
States Government, as defined in 45 C.F.R. Part 76 and 48 C.F.R.
Subparts 9.4 and 309.4 (Debarment Regulations) for a period of two
years beginning on February 28, 1996; the above voluntary exclusion,
however, shall not apply to Dr. Lee's future clinical laboratory
training or practice, unless that training or practice involves
research or research training;
(2) that for a period of one year beginning immediately after the two
year voluntary exclusion above, any institution that submits an
application for PHS support for a research project on which the
Respondent's participation is proposed or which uses the Respondent
in any capacity on PHS supported research, must concurrently submit a
plan for supervision of the Respondent's duties; the supervisory plan
must be designed to ensure the scientific integrity of the
Respondent's research contribution, and the institution must submit a
copy of the supervisory plan to ORI; and
(3) to exclude herself voluntarily from serving in any advisory
capacity to PHS, including but not limited to service on any PHS
advisory committee, board, and/or peer review committee, or as a
consultant for a period of three years beginning on February 28,
1996.
A letter retracting the article entitled "Cyclic-AMP responsive
transcriptional activation of CREB-327 involves interdependent
phosphorylated subdomains" (EMBO Journal 9:4455-4465, 1990) has been
published in the EMBO Journal (EMBO Journal 13:2736, 1994).
INQUIRIES
For further information, contact:
Director, Division of Research Investigations
Office of Research Integrity
5515 Security Lane, Suite 700
Rockville, MD 20852
Telephone: (301) 443-5330
.